Cipla gets HC relief in Roche case

New Delhi: In a ruling that could encourage more generic, or off-patent, drug makers here to challenge patents held my multinational pharma firms, the Delhi high court dismissed a patent infringement suit filed by Swiss pharma company Hoffman-La Roche Ltd for its lung cancer drug Tarceva (generic erlotinib), thereby allowing Indian drug maker Cipla Ltd to continue marketing the generic version of the drug.

A bench of the court, headed by chief justice A.P. Shah, also imposed a cost of Rs5 lakh on Roche for suppressing material facts and not making full disclosure to the court.

“The court has dismissed the appeal with a Rs5 lakh cost,” said Cipla’s counsel Pratibha Singh.

“I think this judgement is really fantastic for cancer patients because there is no injunction against Cipla to sell the drug. But in all likelihood, they (Roche) may appeal to the SC because their whole approach has been very litigatory. They are missing the point that the issue is to the benefit of patients,” said Amar Lulla, joint managing director of Cipla.

When contacted, Roche India managing director Girish Telang, said he had not seen the judgement yet, and would only be able to see it next week. “I am aware of the judgement and the cost of Rs5 lakh. In any case, the judgement will be studied by our headquarters in Switzerland. They will study it properly and then decide what the next course of action should be. I cannot take that decision from here.”

“This will certainly go down as a landmark ruling. I am given to understand that the appellate court held that Roche was not able to establish a prima facie case,” said Shamnad Basheer, a patent expert and a professor in intellectual property law.

Another lawyer familiar with the case, who did not want to be identified, told Mint that the court has come to the conclusion that there is “serious doubt on the validity of Roche’s patent. In view that it is in public interest, we don’t grant this injunction”.

Cipla had launched its generic version of Tarceva, ‘Erlocip’, in December 2007 at a price of Rs1,600 per tablet. The Roche price in the Indian market is Rs4,800 per tablet. However, in an interview to Mint last year, Telang had said that Tarceva “costs Rs3,200 and that’s because we only give out the drug through our company distributor outlets. We have not sold a single strip for Rs4,500 or Rs4,800 as being quoted in the media. Moreover, the Rs3,200 tag includes 32% customs duty. If you remove this duty and then look at the cost, it is only 15% more than that of the generic version”.

In January 2008, Roche filed an infringement suit in the Delhi high court and asked for an injunction that would prevent Cipla from selling Erlocip. Cipla submitted to the court that no injunction should be granted till its post-grant opposition filed in the Delhi patent office was heard and decided upon.

A post-grant opposition is an appeal against a patent that has been granted.

The high court decided the matter on 19 March 2008 in favour of Cipla.

However, Roche re-appealed to a division bench comprising chief justice Shah and justice S. Muralidhar, which completed hearing the case on 15 September.

The validity of Roche’s patent itself would now appear to be in doubt, said Basheer.

“In view of the existence of gefatinib, an earlier known molecule, the court appears to suggest that erlotinib, Roche’s patented molecule, may not be inventive. Secondly, there is a serious doubt about whether or not Cipla infringes the Roche patent at all. Since the court ruled that Roche had not even established a prima facie case, it did not have to go into detail into other factors, such as the pricing of the drug and the public interest factor, something that the trial judge, justice S. Ravindra Bhat had based his judgement on,” he added.

Roche had filed for two patents in India, one for gefatinib (polymorph A+B) and another for erlotinib (polymorph B). In its patent for erlotinib, it had said that gefatinib had an ingredient that was unstable for tablet form. The patent office had granted it a patent for gefatinib.

“...the court is conscious that the defendant (Cipla) has been able to demonstrate prima facie that the plaintiffs (Roche) do not hold a patent yet for Tarceva, which is the polymorph B form of the substance for which they hold a patent. Secondly, the defendant has raised a credible challenge to the validity of the patent held by the plaintiffs. In such circumstances, the public interest in greater public access to a life-saving drug will have to outweigh the public interest in granting an injunction to the patent holder,” stated the judgement, a copy of which has been reviewed by Mint.

A public health lawyer, who has been following the case, closely welcomed the decision. “This judgement will play a key role in the future in similar cases. Its legal precedence is of great importance in the pharmaceutical sector. The most important part of this judgement is that you cannot grant injunctions against the marketing of generics because it effects patients,” she said, asking not to be identified.